Assemblies and methods for infusion pump system administration sets

ABSTRACT

An assembly is configured to position a peristaltic tube with respect to a linear peristaltic pump drive of an infusion pump. The assembly can include a peristaltic tube, first and second tube couplers, a frame, first and second securement plates, a free-flow prevention arm, and a biasing mechanism. The frame can include a snap-fit tab configured to releasably secure the assembly to an assembly receptacle of the infusion pump. The free-flow prevention arm can be selectively movable between a free-flow preventing position and a free-flow allowing position. A latching mechanism can be ergonomically manipulable to latch the free-flow prevention arm in a free-flow allowing position, and to unlatch the free-flow prevention arm such that the biasing mechanism is able to bias the free-flow prevention arm to the free-flow preventing position.

RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.16/309,909 filed Dec. 13, 2018, which is a National Phase entry of PCTApplication No. PCT/US2017/037929 filed Jun. 16, 20217, which claims thebenefit of U.S. Provisional Application No. 62/350,905, filed on Jun.16, 2016, which are hereby fully incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to infusion pump systems, and more particularly,to assemblies and methods for infusion pump system administration sets.

BACKGROUND

Infusion pumps are useful medical devices for managing the delivery anddispensation of many types of therapeutic infusates. Infusion pumpsprovide significant advantages over manual administration by accuratelydelivering infusates over an extended period of time. Infusion pumps areparticularly useful for treating diseases and disorders that requireregular pharmacological intervention, including cancer, diabetes, andvascular, neurological, and metabolic disorders. They also enhance theability of healthcare providers to deliver anesthesia and manage pain.Infusion pumps are used in various settings, including hospitals,nursing homes, and other short-term and long-term medical facilities, aswell as in residential care settings. There are many types of infusionpumps, including ambulatory, large volume, patient-controlled analgesia(PCA), elastomeric, syringe, enteral, and insulin pumps. Infusion pumpscan be used to administer medication through various delivery methods,including intravenously, intraperitoneally, intra-arterially,intradermally, subcutaneously, in close proximity to nerves, and into anintraoperative site, epidural space or subarachnoid space.

In a particular type of infusion pump system that is commonly referredto as a “peristaltic” pump system, delivery of an infusate to a patientis typically accomplished with the use of an infusion administrationset, that is typically disposable after use and can provide a fluidicpathway (e.g., tubing) for the infusate from a reservoir (such as anintra-venous or “IV” bag) to a patient, in cooperation with a pump thatcontrols a rate of flow of the infusate. Peristaltic infusion pumpstypically incorporate a peristaltic pumping mechanism that can functionby repetitively occluding successive sections of tubing of theadministration set in a wave-like motion. For a peristaltic pumpingmechanism to work as intended, proper positioning should be maintainedbetween the portion of tubing (or other element) of the administrationset and the elements of the peristaltic pumping mechanism that interactwith the administration set. In addition, the pump may include devicessuch as occlusion sensors and air-in-line detectors that may requirecorrect placement of the administration set in or with the pump. Apractical peristaltic infusion pump system generally includes a means,method, and/or mechanism by which infusion administration sets (that aretypically disposable, as aforementioned) can be properly engaged withthe pump before infusate delivery is commenced and then disengaged fromthe pump after infusate delivery is performed or completed. It is alsoto be noted that a so-called “large volume pump” or “LVP” systemtypically includes a peristaltic pump and related components asaforedescribed. It is further to be noted that in some publications theterm “volumetric pump” may also be variously used to refer to, whethercorrectly or incorrectly, a peristaltic pump or a large volume pump.

Infusion administration sets preferably include, and may even berequired by law or regulation to include, mechanisms to precludeuncontrolled free-flow of infusate when not engaged with a pump. Such“flow stop” devices may default to or be biased in a free-flowpreventing mode or state when the administration set is not engaged withthe pump. When engaged with the pump, there generally needs to be amechanism to disengage or otherwise act on the flow stop device so thatthe pump can deliver infusate. Further, it may be desirable to allow formanual over-ride of the flow stop device for functions such as primingand/or intentional gravity-fed infusate delivery, when theadministration set is not engaged with the pump.

In view of the multiple functional objectives for infusionadministration sets, there is a desire for improved, easy-to-useadministration sets that reduce burdens on caregivers and increasepatient safety.

SUMMARY

This disclosure relates to infusion pump systems, and more particularly,to assemblies and methods for infusion pump system administration sets.

In an illustrative but non-limiting example, the disclosure provides anassembly configured to position a peristaltic tube with respect to alinear peristaltic pump drive of an infusion pump. The assembly caninclude a peristaltic tube, first and second tube couplers, a frame,first and second securement plates, a free-flow prevention arm, and abiasing mechanism.

The peristaltic tube can be formed of a resilient material and can besuitable for compression by the linear peristaltic pump drive of thepump. The first and second tube couplers can be attached at opposingends of the peristaltic tube, with each of the first and second tubecouplers having a lumen in fluidic communication with the peristaltictube.

The frame can include a first beam and a second beam substantiallyparallel to the first beam, the first and second beams substantiallylying in a first plane. In some cases, at least one of the first andsecond beams can be substantially L-shaped. The frame also can include afirst end plate joining the first and second beams at a first end, and asecond end plate joining the first and second beams at a second end,with the first and second end plates substantially lying in the firstplane. The first beam can include a snap-fit tab projecting away fromthe first plane in a first direction and a snap release handleoperatively coupled to the snap-fit tab. The snap-fit tab can beconfigured to releasably secure the assembly to an assembly receptacleof the infusion pump, such that when the assembly is secured via thesnap-fit tab to the assembly receptacle, the peristaltic tube ispositioned for engagement with the linear peristaltic pump drive of thepump. A defined manipulation of the snap release handle can release thesnap-fit tab and therefore the assembly from the assembly receptacle.

The assembly can also include a first securement plate configured tocooperate with the first end plate to couple the first tube coupler tothe frame, and a second securement plate configured to cooperate withthe second end plate to couple the second tube coupler to the frame.

The assembly can include a free-flow prevention arm coupled to the frameat an arm end and having a latching structure configured to cooperatewith a latching receiver of the frame, such that the latching structureand the latching receiver together provide a latching mechanism. Thefree-flow prevention arm can be selectively movable between a free-flowpreventing position and a free-flow allowing position. In the free-flowpreventing position, the free-flow prevention arm and the frame cansqueezingly occlude the peristaltic tube; in the free-flow allowingposition, the free-flow prevention arm and the frame can be relativelypositioned to allow the peristaltic tube to pass therebetween such thatthe peristaltic tube is not squeezingly occluded. The latching mechanismcan be ergonomically manipulable to latch the free-flow prevention armin a free-flow allowing position. The biasing mechanism of the assemblycan be configured to bias the free-flow prevention arm to the free-flowpreventing position. The latching mechanism of the assembly can beergonomically manipulable to unlatch the free-flow prevention arm suchthat the biasing mechanism is able to bias the free-flow prevention armto the free-flow preventing position.

In some instances, the latching structure of the free-flow preventionarm can include a thumb press surface and latching receiver of the framecan include a finger press surface.

In some cases, the latching structure of the free-flow prevention armcan include a release catch. The release catch of the latching structureof the free-flow prevention arm can be structured to provide a surfacefor a human finger to flex the free-flow prevention arm sufficiently tounlatch the latching mechanism. The release catch of the latchingstructure of the free-flow prevention arm can be structured to cooperatewith at least one ramp in the assembly receptacle of the infusion pumpso that when the assembly is secured to the assembly receptacle, therelease catch slides along the ramp(s) as the free-flow prevention armis moved toward the free-flow allowing position, such that force exertedon the release catch by the ramp(s) flexes the free-flow prevention armsufficiently to prevent the latching mechanism from latching in thefree-flow allowing position. Alternatively or in addition, the releasecatch of the latching structure of the free-flow prevention arm can bestructured to cooperate with at least one ramp in the assemblyreceptacle of the infusion pump such that if, before the assembly issecured to the assembly receptacle, the latching mechanism is latched inthe free-flow allowing position, then subsequently when the assembly issecured to the assembly receptacle via the snap-fit tab, the ramp(s)exerts force on the release catch adequate to flex the free-flowprevention arm sufficiently that the latching mechanism is released.

In some cases, the biasing mechanism can include a spring formedseparately from the frame and from the free-flow protection arm, thespring being captured between the frame and the free-flow protectionarm.

In some cases, the free-flow prevention arm can be hingedly coupled tothe frame at the arm end. In some such instances, the free-flowprevention arm can be hingedly coupled to the frame at the arm end via ahinge mechanism that substantially does not impart torque between thefree-flow prevention arm and the frame.

In some cases, the latching mechanism can be ergonomically manipulablewith a single hand to latch the free-flow prevention arm in thefree-flow allowing position.

In some cases, the latching mechanism can be ergonomically manipulablewith a single hand to unlatch the free-flow prevention arm such that thebiasing mechanism is able to bias the free-flow prevention arm to thefree-flow preventing position.

In some instances, the frame can define a slot transverse to theperistaltic tube and generally aligned with the free-flow preventionarm, such that when the free-flow prevention arm is in the free-flowpreventing position, the free-flow prevention arm can press theperistaltic tube at least partially into the slot. In some suchinstances, the frame can include a buttress spanning the slot, with thebuttress generally aligned with the peristaltic tube. The buttress canprovide a guard against accidental latching of the latching mechanism.

In some cases, the assembly can include an identifier containinginformation related to a particular route of infusion associated withthe assembly. In some cases, the identifier is a colored surface or tagproviding an associated visible or infrared optical wavelength fordetection. In other cases, the identifier includes at least one of: anRFID tag, a magnetic key, an identifying pin configuration or aprotrusion of identifying size and shape.

In another illustrative but non-limiting example, the disclosureprovides an infusion pump system that includes an infusion pump that hasassembly receptacle, and a disposable assembly configured to position aperistaltic tube with respect to a linear peristaltic pump drive of theinfusion pump. The disposable assembly can be structured and configuredsubstantially as aforedescribed in the first illustrative butnon-limiting example of this Summary.

In some cases, the assembly receptacle can define at least one ramp, andthe release catch of the latching structure of the free-flow preventionarm can be structured to cooperate with the ramp(s) in the assemblyreceptacle of the infusion pump so that when the assembly is secured tothe assembly receptacle, the release catch slides along the ramp(s) asthe free-flow prevention arm is moved toward the free-flow allowingposition, such that force exerted on the release catch by the ramp(s)flexes the free-flow prevention arm sufficiently to prevent the latchingmechanism from latching in the free-flow allowing position.

In some cases, the infusion pump can further include a receptacle doorthat can open and close to allow or block access to the assemblyreceptacle. The receptacle door can include a free-flow protection armpusher and a door latch lever that are operatively coupled such thatwhen the assembly is received by the assembly receptacle and thereceptacle door is closed, the free-flow protection arm pusher can pushthe free-flow protection arm from the free-flow preventing position tothe free-flow allowing position as the door latch lever is moved from anunlatched position to a latched position.

In some cases, a system includes an infusion pump having an assemblyreceptacle and a disposable assembly. The assembly receptacle includes asensing device that detects route of infusion information from anidentifier on the assembly. In certain cases, the sensing device is anoptical sensor. In other cases, the sensing device includes at least oneof: an RFID reader, a magnetic key reader, and a pin identifier.

In yet another illustrative but non-limiting example, the disclosureprovides an assembly configured to position a peristaltic tube withrespect to a linear peristaltic pump drive of an infusion pump. Theassembly can include a peristaltic tube, a frame, first and second tubesupports, and a free-flow prevention arm.

The peristaltic tube can be formed of a resilient material and can besuitable for compression by the linear peristaltic pump drive of thepump.

The frame can include a beam and a latching receiver.

The first tube support can be positioned at a first end of the beam ofthe frame, and the second tube support positioned at a second end of thebeam of the frame. The first tube support and the second tube supportcan be configured to maintain the position of the peristaltic tube withrespect to the frame.

The free-flow prevention arm can be attached to the frame at an arm endand can have a latching structure configured to cooperate with thelatching receiver of the frame, such that the latching structure andlatching receiver together providing a latching mechanism. The free-flowprevention arm can be movable between a free-flow preventing positionand a free-flow allowing position. In the free-flow preventing position,the free-flow prevention arm and the frame can squeezingly occlude theperistaltic tube, and in the free-flow allowing position, the free-flowprevention arm and the frame can allow the peristaltic tube to passtherebetween such that the peristaltic tube is not occluded. Thelatching mechanism, in a latched state, can constrain the free-flowprevention arm to the free-flow allowing position. In an unlatchedstate, the latching mechanism may not constrain the free-flow preventionarm to the free-flow allowing position. The latching mechanism can bemanipulable with a single hand to move to the latched state, and canfurther be manipulable with a single hand to move to the unlatchedstate.

In some cases, the beam can include a snap-fit tab projecting away fromthe beam, and can also include a snap release handle operatively coupledto the snap-fit tab. The snap-fit tab can be configured to releaseblysecure the assembly to an assembly receptacle of the infusion pump. Whenthe assembly is secured via the snap-fit tab to the assembly receptacle,the peristaltic tube can be positioned for engagement with the linearperistaltic pump drive. Manipulation of the snap release handle canrelease the snap-fit tab and thereby the assembly from the assemblyreceptacle.

In some cases, the assembly can be configured to releasably secure to anassembly receptacle of the infusion pump. The latching structure of thefree-flow prevention arm can include a release catch structured toprovide purchase for a human finger to flex the free-flow prevention armsufficiently to unlatch the latching mechanism. The release catch of thelatching structure of the free-flow prevention arm can be structured tocooperate with at least one ramp in the assembly receptacle of theinfusion pump such that if, before the assembly is secured to theassembly receptacle, the latching mechanism is latched in the free-flowallowing position, then subsequently when the assembly is secured to theassembly receptacle, the ramp(s) can exert force on the release catchadequate to flex the free-flow prevention arm sufficiently that thelatching mechanism is released.

In another illustrative but non-limiting example, the disclosureprovides an assembly configured to position a peristaltic tube withrespect to a linear peristaltic pump drive of an infusion pump. Theassembly includes a peristaltic tube, a first tube and second tubecouplers, a frame, a free-flow prevention arm, and a biasing mechanism.The peristaltic tube is suitable for compression by the linearperistaltic pump drive. The first tube coupler and the second tubecoupler are each attached at opposing ends of the peristaltic tube. Thefirst tube coupler and the second tube coupler each have a lumen influidic communication with the peristaltic tube. The frame is coupled tothe first tube coupler and the second tube coupler at spaced-apartlocations. The frame is configured for releasable attachment to theinfusion pump such that the peristaltic tube is positioned forengagement with the linear peristaltic pump drive. The frame furtherincludes a latching receiver projecting from the frame having a fingerpress surface. The free-flow prevention arm is hingedly coupled to theframe at an arm end and has a latching structure sized to cooperate withthe latching receiver. The latching structure includes a thumb presssurface projecting outwardly from the arm, and a release catch disposedat a spaced-apart location from the thumb press surface. The fingerpress surface of the latching receiver and the thumb press surface ofthe latching structure are oppositely-disposed and operatively coupledin close proximity for ergonomic manipulation with a single hand toselectively latch and unlatch the latching receiver of the free-flowprevention arm between a free-flow preventing position and a free-flowallowing position. The biasing mechanism is located between the frameand the free-flow protection arm, configured to bias the free-flowprevention arm to the free-flow preventing position.

In some cases, the frame includes a snap-fit tab and a snap releasehandle. In some cases, the frame includes an identifier containinginformation related to a route of infusion associated with the assembly.In some cases, the identifier is a colored surface or tag providing anassociated visible or infrared optical wavelength for detection. In somecases, the identifier contains at least one of: an RFID tag, a magnetickey, an identifying pin configuration, and an identifying protrusion.

The above summary is not intended to describe each and every example orevery implementation of the disclosure. The Description that followsmore particularly exemplifies various illustrative embodiments.

BRIEF DESCRIPTION OF THE FIGURES

The following description should be read with reference to the drawings.The drawings, which are not necessarily to scale, depict examples andare not intended to limit the scope of the disclosure. The disclosuremay be more completely understood in consideration of the followingdescription with respect to various examples in connection with theaccompanying drawings, in which:

FIG. 1 is a schematic perspective view of an example embodiment of aperistaltic infusion pump system that includes a peristaltic pump andadministration set;

FIG. 2 is a front schematic perspective view of an example assembly ofthe administration set of FIG. 1;

FIG. 3 is a back schematic perspective view of the assembly of FIG. 2;

FIG. 4 is a front schematic perspective exploded view of the assembly ofFIG. 2;

FIG. 5 is a back schematic perspective exploded view of the assembly ofFIG. 2;

FIG. 6 is a schematic quasi-sectional view of a portion of the assemblyof FIG. 2 showing a free-flow prevention arm in a free-flow preventingstate;

FIG. 7 is a schematic quasi-sectional view of the portion of theassembly illustrated in FIG. 6, showing the free-flow prevention arm ina free-flow allowing state;

FIG. 8 is a schematic perspective view of portions of an exampleperistaltic infusion pump, which can be the pump of FIG. 1, particularlyillustrating details of an assembly receptacle and a receptacle door ofthe pump;

FIG. 9 is a schematic perspective view of portions of the peristalticinfusion pump of FIG. 8, with the assembly of FIG. 2 received by theassembly receptacle of the pump;

FIG. 10 is a schematic perspective view of portions of the peristalticinfusion pump of FIG. 8 with the receptacle door in a closed positionand a door latch lever in an unlatched position;

FIG. 11 is a schematic perspective view of portions of the peristalticinfusion pump of FIG. 8 with the receptacle door in the closed positionand the door latch lever in a latched position;

FIG. 12 is a schematic perspective view of an alternative embodiment ofa frame for an assembly similar to that of FIGS. 2-7;

FIG. 13 is an alternative embodiment of a schematic perspective view ofportions of an example peristaltic infusion pump, which can be the pumpof FIG. 1, particularly illustrating details of an assembly receptacleand a receptacle door of the pump;

FIG. 14 is an alternative embodiment of a back schematic perspectiveview of the assembly of FIG. 2;

FIGS. 15A-E are examples of sensing devices of a pump utilizing magnetickeying devices for assembly identification or information;

FIGS. 16A-D are top and perspective view examples of sensing devices ofa pump for receiving pin configuration identifiers for assemblyidentification or information; and

FIGS. 17A-C are top view examples of sensing devices of a pump forreceiving protrusions of various shapes and sizes for assemblyidentification or information.

DESCRIPTION

The following description should be read with reference to the drawings,in which like elements in different drawings may be numbered in likefashion. The drawings, which are not necessarily to scale, depictselected examples and are not intended to limit the scope of thedisclosure. Although examples of construction, dimensions, and materialsmay be illustrated for the various elements, those skilled in the artwill recognize that many of the examples provided have suitablealternatives that may be utilized.

FIG. 1 is a schematic perspective view of an example embodiment of aperistaltic infusion pump system 100 that includes a peristaltic pump102 and a disposable administration set 104 that is structured andconfigured to operatively couple to pump 102. In FIG. 1, administrationset 104 is illustrated as not coupled to pump 102.

Pump 102 can include a housing 106 and a user interface 108 (that caninclude, for example, a display screen, keypad, audio speaker, and anyother suitable user interface components) for prompting and/or relayingcommands to a control system or controller (not illustrated) of pump102, and/or for communicating from/to the controller to/from users. Userinterface 108 generally can allow a user to enter various parameters,including but not limited to names, drug information, limits, deliveryshapes, information relating to hospital facilities, as well as varioususer-specific parameters (e.g., patient age and/or weight) along withso-called “five rights” verification or inputs. Pump 102 can include anyappropriate wired or wireless input/output (I/O) interface port and/orprotocol (including, but not limited to, USB, Ethernet, WiFi, NFC,Bluetooth, ZigBee, IrDA, and the like) for connecting pump 102 to anetwork or computer (not illustrated) having software designed tointerface with pump 102.

User inputs to pump 102 can be provided by programming from anauthorized user, such as a patient, pharmacist, scientist, drug programdesigner, medical engineer, nurse, physician, or other authorizedmedical practitioner or healthcare provider. User inputs may utilizedirect interfacing (via, e.g., keyboards, touch screens, or othertouch-based inputs) as shown, and/or user inputs may utilize indirect or“touchless” interfacing (i.e., gestures; voice commands; facialmovements or expressions; finger, hand, head, body and arm movements; orother inputs that do not require physical contact such as cameras,sensors of electric field, capacitance, or sound). User inputs generallycan be interfaced, communicated, sensed, and/or received by operatorinput mechanisms of user interface 108.

In the present disclosure, a controller of a pump can be any suitablecontroller, microcontroller, microprocessor, or the like. Such acontroller can include and/or be operatively coupled to any otherhardware or software resource needed for its function, such as anysuitable memory of any suitable capacity, containing any suitablesoftware, firmware, operating parameters, and so on. The controller canbe configured and programmed to execute, command, and/or perform anysuitable actions, tasks, steps, and/or methods for controlling the pump.The pump can include a plurality of physically and/or logically distinctcontrollers, such as application-specific processors. In the presentdisclosure, a plurality of such controllers of a pump may be referred tocollectively in the singular as the controller of the pump. As mentionedelsewhere herein, methods of the present disclosure can be implementedby the controller of a pump, and/or in some instances by anothercontroller, such as by a controller of another pump, a system of pumps,a controller implemented on a server, or any other appropriatecontroller. As such, any reference in the present disclosure to acontroller in the singular should not be interpreted as strictlylimiting to a single physical or logical controller (unless explicitlylimited to a single controller), but rather, can include systems and/ormethods in which controller functions are provided by one or morecontrollers.

Power to infusion pump 102 can be provided via an AC or DC power cord orfrom an internally provided battery source (not illustrated), or by anyother suitable means. Embodiments can also include a wireless powersource (not illustrated).

Pump 102 can include an assembly receptacle 112 configured to receive anassembly 114 of the administration set 104, and a receptacle door 116that can open and close to allow or block access to assembly receptacle112. Tube-engaging members 118 of a linear peristaltic pump drive can belocated in assembly receptacle 112. As discussed in further detailherein, assembly 114 of administration set 104 can be configured andstructured to position elements of set 104 in an operative relationshipwith the linear peristaltic pump drive, including tube-engaging members118.

Administration set 104 can provide a fluidic pathway from an IV bag 120or other infusate reservoir to an infusion set 122 that ultimatelydelivers infusate(s) to a patient 124. It is to be appreciated andunderstood that, although the present disclosure refers to an IV bag 120or other infusate reservoir and an administration set 104 (therebyimplying only one reservoir, one infusate substance, and oneadministration set), subject matter hereof could include or beapplicable to a plurality of same, similar, or different infusatereservoirs, infusates, and administration sets. Administration set 104can include, in addition to assembly 114, upstream tubing 126 that canextend from IV bag 120 or other reservoir to assembly 114. Upstreamtubing 126 can terminate in a bag spike 128 or other connector.Administration set 104 can also include downstream tubing 130 that canextend from assembly 114 to infusion set 122. Downstream tubing 130 canbe fluidically coupled to infusion set 122 or other catheter withconnector 132 such as a Luer-type connector or any other suitableconnector, such as one of those contemplated, specified, defined, ordescribed by one of the ISO 80369 series of small bore connectorstandards.

FIGS. 2 and 3 are front and back schematic perspective views,respectively, of an example assembly 200, which can be assembly 114 ofadministration set 104 of FIG. 1. FIGS. 4 and 5 are front and backschematic perspective exploded views, respectively, of assembly 200. Theadjectives “front” and “back” are used in relation to the orientation ofassembly 200 when received by assembly receptacle 112 of pump 102, withthe back side of the assembly facing inwardly toward the pump, and thefront side of the assembly facing outwardly away from the pump.Elsewhere in this disclosure, descriptors such as “top,” “upper,”“bottom,” and “lower” may be used, which those of ordinary skill willrecognize in relation to the normal orientation of system 100 andassembly 200 with respect to the surface of the earth. In most or allFigures of the present disclosure, assembly 114 and components thereofare illustrated oriented with their top or upper portions toward the topsides of the pages on which they are printed or rendered.

Assembly 200 can include a peristaltic tube 202 formed of a resilientmaterial that is suitable for compression (and recovery fromcompression) by the linear peristaltic pump drive of pump 102. In someembodiments, peristaltic tube 202 is formed from silicone. In otherembodiments, polyvinyl chloride, polyurethane, latex rubber, or anyother suitable compressible resilient material can be used. At opposingends of peristaltic tube 202, assembly 200 can include first and secondtube couplers 204 a, 204 b. Tube couplers 204 a and 204 b can beidentical in structure, as in the illustrated example embodiment ofassembly 200, but in some embodiments tube couplers may not beidentical. Tube couplers 204 a, 204 b can function to fluidically couplethe peristaltic tube 202 with upstream tubing 126 and downstream tubing130 illustrated in FIG. 1 (but not illustrated in FIGS. 2-5 and 8-11),respectively. Tube couplers 204 a, 204 b can include lumens 206 a, 206 b(as illustrated, e.g., in FIGS. 3 and 2, respectively) that can be influidic communication with peristaltic tube 202 and/or upstream tubing126 and downstream tubing 130, respectively, when the corresponding tubecoupler is coupled to the corresponding tube/tubing. Note that in theexample embodiment of assembly 200, tube coupler 204 a can be coupled toupstream tubing 126 and tube coupler 204 b can coupled to downstreamtubing 130, but this is not limiting and in some embodiments thecoupling correspondence could be reversed.

Tube couplers 204 a, 204 b can be manufactured or formed from, orotherwise include, any suitable material or materials. In someembodiments, tube couplers 204 a, 204 b can be formed from acrylonitrilebutadiene styrene (ABS). In other embodiments, polycarbonate, polyester,polypropylene, polyvinyl chloride or any other suitable semi-rigidmaterial can be used.

Tube couplers 204 a, 204 b can include peristaltic tube receivingportions 208 a, 208 b as illustrated in FIG. 4, dimensioned to receiveand engage interior surfaces of peristaltic tube 202 by way of afriction fit in each. Peristaltic tube 202 may be stretched or otherwiseexpanded in order to fit around peristaltic tube receiving portions 208a, 208 b. The fit between peristaltic tube 202 and peristaltic tubereceiving portions 208 a, 208 b can result in a fluidic seal between thetube 202 and tube coupler 204 a, 204 b. Relative dimensions of theperistaltic tube 202 and peristaltic tube receiving portions 208 a, 208b can be selected to affect such sealing. In some embodiments, anadhesive or other bonding agent can be used for attaching peristaltictube 202 and peristaltic tube receiving portions 208 a, 208 b, but thisis not required. In some embodiments, a swelling or lubricating agentmay be used during assembly. Opposite peristaltic tube receivingportions 208 a, 208 b, lumens 206 a, 206 b can be dimensioned to receiveupstream tubing 126 and downstream tubing 130, where the couplers andtubing can be adhered or otherwise bonded. These ways for providingcoupling between tube couplers 204 a, 204 b and peristaltic tube 202and/or upstream tubing 126 and downstream tubing 130 should not beconstrued as limiting, and in other embodiments other arrangements andvariations are possible.

As illustrated in FIGS. 2-5, assembly 200 can include a frame 210configured to receive tube couplers 204 a, 204 b and therebysubstantially hold peristaltic tube 202 when coupled to the tubecouplers, in a substantially defined position relative to frame 210.Frame 210 can include a first beam 212 and can also include a secondbeam 214 that is substantially parallel to first beam 212. Thesubstantially parallel first beam 212 and second beam 214 can liesubstantially in, or define, a first plane (not illustrated). In thisnon-limiting example, either or both beams 212, 214 can be “L” shaped,as illustrated, although this is not required in all embodiments. When“L” shaped, one leg of the “L” can lie in the first plane, and the otherleg of the “L” can be perpendicular to the first plane.

At a first end, frame 210 can include a first end plate 216 joiningfirst and second beams 212, 214, with first end plate 216 substantiallylying in the first plane of first and second beams. 212, 214. At asecond end, frame 210 can include a second end plate 218 joining firstand second beams 212, 214, with second end plate 218 substantially lyingin the first plane of first and second beams 212, 214. First end plate216 and second end plate 218 can each define a channel 220 a, 220 b(respectively; visible, for example, in FIG. 5) configured to receivecorresponding tube coupler 204 a, 204 b.

Corresponding to first end plate 216 and second end plate 218, assembly200 can include a first securement plate 224 a and a second securementplate 224 b respectively, that are structured and configured tocooperate with end plates 216, 218 to couple tube couplers 204 a, 204 bto frame 210. Similarly to first and second end plates 216, 218, firstand second securement plates 224 a, 224 b can each define a channel 226a, 226 b (respectively; visible, for example, in FIG. 4) configured toreceive corresponding tube coupler 204 a, 204 b.

Frame 210 (including end plates 216, 218) and securement plates 224 aand 224 b, can be manufactured or formed from, or otherwise include, anysuitable material or materials. In some embodiments, these componentscan be formed from acrylonitrile butadiene styrene (ABS). In otherembodiments, polycarbonate, polyester, polypropylene, polyvinyl chlorideor any other suitable semi-rigid material can be used.

First and second end plates 216, 218 can be mated to first and secondsecurement plates 224 a, 224 b, respectively, with first and second tubecouplers 204 a, 204 b positioned or held (or colloquially, “sandwiched”)between each mated corresponding pair of end plates and securmentplates. Any suitable structures and/or means can be used to hold thepairs of end and securement plates together when mated. In illustratedexample assembly 200, end plates 216, 218 and securement plates 224 a,224 b, can be respectively joined by ultrasonic welding. End plates 216,218 and securement plates 224 a, 224 b can be structured and configuredwith features to facilitate ultrasonic welding. For example, securementplates 224 a, 224 b can include bars 230 (visible in FIG. 4) that caninclude ultrasonic welding energy directors, and end plates 216, 218 caninclude slots 232 (visible in FIG. 5) dimensioned and positioned toreceive the bars 230. As illustrated in this example of assembly 200,each securement plate 224 a, 224 b includes four bars 230 that aresubstantially identical in shape, and each end plate 216, 218 includesfour slots 232 also substantially identical in shape, but it is notnecessary for all bars and slots to have the same shapes, nor is thequantity of four bars/slots required for each pair of plates. Variationsin number, location, and shapes of ultrasonic welding components arepossible. In some embodiments, asymmetries in ultrasonic weldingcomponents could be used to prevent mis-oriented (e.g., upside-down,reversed, etc.) attachment of securement plates 224 a, 224 b to endplates 216, 218. In some embodiments, including that of FIGS. 2, 3, 4,and 5, securement plates 224 a, 224 b can have essentially the same oridentical structure, which could be advantageous for manufacturing,inventory, assembly, and/or performance.

In some embodiments, methods, materials, and/or means for holding pairsof securement and end plates together other than, or in addition to,ultrasonic welding can be used. In some cases, snap fasteners, screws,rivets, slide fasteners, clips, adhesives, heat staking, solventwelding, or any other suitable attachment technology could be employed.

In illustrated example assembly 200, securement plates 224 a, 224 b canbe structurally unattached to end plates 216, 218 (as in FIGS. 4 and 5)before the pairs of plates are mated, but other configurations arepossible. FIG. 12 is a schematic perspective view of an alternativeembodiment of a frame 1210 with end plates 1216, 1218 that are hingedlyattached to corresponding securement plates 1224 a, 1224 b via hinges1234 a, 1234 b. Hinges 1234 a, 1234 b could be thin, flexible elements;frame 1210, securement plates 1224 a, 1224 b, and the hinges could bemanufactured together as a single piece in an injection molding process.This is just one example of how a frame and hingedly attached butun-mated securement plates could be provided. Such an arrangement couldbe advantageous for manufacturing, inventory, assembly, and/orperformance.

With reference again to FIG. 2, et seq., when assembly 200 is assembled(with peristaltic tube 202 coupled to tube couplers 204 a, 204 b and thetube couplers positioned between mated pairs of end plates 216, 218 andsecurement plates 224 a, 224 b), peristaltic tube 202 can be compressedat each end between each end's tube coupler and plates. Compression ofperistaltic tube 202 between tube couplers 204 a, 204 b, end plates 216,218, and securement plates 224 a, 224 b can enhance fluidic sealingbetween the tube and the tube couplers. Dimensions of these componentscan be selected to affect such sealing, while avoiding problems such asover-compression that could damage materials, and/or cause difficultiesin ultrasonic welding.

End plates 216, 218 of frame 210, securement plates 224 a, 224 b, andtube couplers 204 a, 204 b can include further features that cancooperate to define or substantially constrain their positionalrelationship when assembled. End plates 216, 218 and securement plates224 a, 224 b can define arcs or ridges 236 that extend into channels 220a, 220 b, 226 a, 226 b. Tube couplers 204 a, 204 b can definecircumferential slots 238 corresponding to ridges 236 such that whensecurement plates 224 a, 224 b are mated to end plates 216, 218 withtube couplers 204 a, 204 b positioned or held therebetween, mechanicalcorrespondence of ridges 236 to slots 238 can substantially constraintube couplers 204 a, 204 b translationally with respect to end plates216, 218 and securement plates 224 a, 224 b, and also can substantiallyconstrain rotational motion. If rotation about a longitudinal axisaligned with peristaltic tube 202 is defined as “roll,” then “pitch” and“yaw” rotations about orthogonal axes can be constrained substantiallyby mechanical correspondence of ridges 236 to slots 238. “Roll” typerotations of tube couplers 204 a, 204 b relative to end plates 216, 218and securement plates 224 a, 224 b can be substantially constrained byultrasonic welding, although this is not limiting and other means can beused to constrain roll, such as by way of mechanical keying or adhesivebonding. Energy directors 240 can be provided on securement plates 224a, 224 b to facilitate ultrasonic welding of end plates 216, 218 to tubecouplers 204 a, 204 b. Tube couplers 204 a, 204 b can be rotationallysymmetric substantially, about a longitudinal axis. Such substantialsymmetry can simplify assembly (discussed elsewhere herein) of assembly200.

Tube coupler 204 a, first end plate 216, and first securement plate 224a can be considered collectively as a first tube support, and tubecoupler 204 b, second end plate 218, and second securement plate 224 bcan be considered collectively as a second tube support, where such tubesupports are configured to substantially maintain a position ofperistaltic tube 202 with respect to frame 210, and with respect toassembly 200. In other embodiments, other hardware configurations couldbe employed to provide tube supports configured to substantiallymaintain the position of a peristaltic tube with respect to a frame andassembly. As just one example, although not illustrated, arrangementswhere tube couplers secure to end plates or the like without securementplates can be contemplated.

Components of assembly 200 can be structured and dimensioned such that,when assembly 200 is assembled, manufactured, or otherwise produced,peristaltic tube 202 is maintained in position with respect to frame 210such that it is held essentially straight between tube couplers 204 aand 204 b (or, alternately described, between the first and second tubesupports). This can help ensure that tube 202 is properly positioned andaligned with respect to pump 800 and components of pump 800 thatinteract with tube 202 when assembly 200 is mated thereto or installedtherein, as described in further detail elsewhere herein. The length ofperistaltic tube 202 can be specified with tolerances to achieve thisessentially straight positioning. The length of tube 202 at maximumtolerance can be such that there will be essentially no slack orbuckling in the tube when assembled into assembly 200. At shorterlengths than maximum tolerance, such as a minimum tolerance, peristaltictube 202 can be assembled into assembly 200 with a small amount oftension, slightly stretched between tube couplers 204 a and 204 b(between the first and second tube supports).

With reference to FIG. 2, et seq., assembly 200 can include features toselectively prevent free-flow of infusate through the peristaltic tube202. Assembly 200 can include a free-flow prevention (FFP) arm 246 thatcan be coupled to frame 210 at an arm end 248, and that can include alatching structure 250. Arm 246 can be hingedly coupled to frame 210 viaone or more hinge pins 252 (two are illustrated in, e.g., FIG. 4) at armend 248, and a hinge receiver 254 of frame 210 as illustrated in, e.g.,FIG. 5, with hinge receiver 254 having one or more sockets correspondingto the one or more hinge pins 252. In illustrated example assembly 200,hinge receiver 254 is part of or proximate to first end plate 216, butthis is not limiting and other locations on frame 210 for FFP arm 246are possible in some embodiments. The hinge mechanism for FFP arm 246that includes hinge pin(s) 252 and hinge receiver 254 can be providedsuch that it does not impart torque and/or rotational bias does notsubstantially occur between FFP arm 246 and frame 210. In otherembodiments, other designs for substantially torque-free hingemechanisms are contemplated and could be used to couple a FFP arm to aframe.

FFP arm 246 can be manufactured or formed from, or otherwise include,any suitable material or materials. In some embodiments, FFP arm 246 canbe formed from acrylonitrile butadiene styrene (ABS). In otherembodiments, polycarbonate, polyester, polypropylene, polyvinyl chlorideor any other suitable semi-rigid material can be used.

FFP arm 246 can be selectively movable relative to frame 210 between afree-flow preventing position and a free-flow allowing position.Examples of these positions are depicted in FIGS. 6 and 7, respectively,which are schematic quasi-sectional views of portions of assembly 200 ata sectional cut through the assembly at the FFP arm 246, as indicated byline A-A in FIG. 2. (The views are not true cross-sectional views, asportions of the assembly further away than the sectional cut are visiblyrendered in the views.) In FIG. 6, FFP arm 246 is illustrated in thefree-flow preventing position, in which arm 246 and frame 210 cancooperate to squeezingly occlude peristaltic tube 202 in a relativelynarrower space 256 between arm 246 and frame 210. (In FIGS. 2 and 3, FFParm 246 also is illustrated in the free-flow preventing position.) InFIG. 7, FFP arm 246 is illustrated in the free-flow allowing position,in which arm 246 and frame 210 can be relatively positioned to allowperistaltic tube 202 to pass therebetween in a relatively wider space257 (compared to space 256) between arm 246 and frame 210 such that tube202 is not squeezingly occluded.

With continued reference to FIGS. 6 and 7, assembly 200 can include abiasing mechanism configured to bias FFP arm 246 to the free-flowpreventing position. Assembly 200 can include, for example, a spring 258that can exert forces on frame 210 and FFP arm 246 to bias arm 246 tothe free-flow preventing position. Spring 258 can be any suitablespring, such as a metal coil spring. Spring 258 can be formed separatelyfrom frame 210 and from FFP arm 246. Spring 258 can be captured betweenframe 210 and FFP arm 246. Frame 210 can receive portions of spring 258in a spring pocket 259, and FFP arm 246 can substantially retain spring258 at a spring pin 261 as illustrated.

Other configurations of biasing mechanisms are possible. In anotherembodiment, a biasing force can be provided by a resilient element (suchas, but not limited to, a leaf-spring) formed integrally with the frame,but separately from the FFP arm, or formed integrally with the FFP arm,but not the frame. In another embodiment, a biasing force can beprovided by a suitable arrangement of magnets.

In another embodiment, although not illustrated herein, an FFP arm canbe coupled to a frame via a non-rotating or rigid connection rather thanthe pin(s) 252 and socketed hinge receiver 254 arrangement as inillustrated assembly 200, with a “hinge” provided by flexure of the FFParm allowing elastic deformation of the arm between free-flow preventingand allowing positions, and such flexure also providing a biasing forcetoward the free-flow preventing position.

As depicted in, e.g., FIG. 5, frame 210 can define a slot 272 transverseto the longitudinal axis of peristaltic tube 202 and generally alignedwith FFP arm 246. When FFP arm 246 is in the free-flow preventingposition, arm 246 can press the peristaltic tube 202 at least partiallyinto slot 272. When tube 202 is squeezingly occluded between FFP arm 246and frame 210, it may more specifically be squeezed between the arm 246and one or both edges of frame 210 that define slot 272. Slot 272 can bedimensioned to permit FFP arm 246 to move freely (that is, not tointerfere with arm 246) about a typical range of motion of arm 246.

As depicted in, e.g., FIG. 4, frame 210 can include a buttress 274spanning slot 272. Buttress 274 can be aligned generally with thelongitudinal axis of peristaltic tube 202. Buttress 274 can reinforce orstiffen a portion of frame 210 about slot 272 and provide otherfunctions described elsewhere herein. Buttress 274 can be located on aside of frame 210 opposite a side from which FFP arm 246 can pressperistaltic tube 202 toward frame 210 and slot 272. Buttress 274 can belocated on a same side of frame 210 as a thumb press surface 266 of FFParm 246 (as shown in, e.g., FIG. 2 and also described further elsewhereherein). Buttress 274 can be located on a same side of frame 210 as asnap release handle 278 (as shown in, e.g., FIG. 2 and also describedfurther elsewhere herein).

With continued reference to FIGS. 6 and 7, frame 210 can include alatching receiver 260 configured to cooperate with latching structure250 of FFP arm 246, such that latching receiver 260 and latchingstructure 250 together provide a latching mechanism for FFP arm 246. Thelatching mechanism can be structured such that it is ergonomicallymanipulable (in some cases, with a single hand) to latch FFP arm 246 inthe free-flow allowing position (shown in FIG. 7), and it can bestructured such that it is ergonomically manipulable (in some cases,with a single hand) to unlatch FFP arm 246 to the free-flow preventingposition (shown in FIG. 6), as described further herein. The latchingmechanism can be regarding as having two states, a latched state (FIG.7) and an unlatched state (FIG. 6). In the latched state, latchingstructure 250 can bear against a latching surface 262 of latchingreceiver 260 such that FFP arm 246 is essentially thereby constrained toa position corresponding to relatively wider space 257 as shown in FIG.7. In the unlatched state, latching structure 250 can be positioned sothat it does not bear against latching surface 262, but rather,structure 250 can slidingly bear against a sliding surface 264 ofreceiver 260. In the unlatched state, a biasing force such as thatprovided by spring 258, if present, can bias FFP arm 246 toward thefree-flow preventing position corresponding to relatively narrower space256 as shown in FIG. 6. Sliding surface 264 can be structured with adraft angle that, via interaction with latching structure 250, aids(rather than hinders) motion of the FFP arm 246 toward the free-flowpreventing position.

With regard to the potentially ergonomic manipulability of the latchingmechanism, latching structure 250 of FFP arm 246 can include a thumbpress surface 266 and latching receiver 260 can include a finger presssurface 268. While referred to as “thumb” press 266 and “finger” press268, this nomenclature should not be considered limiting, and thepresses 266 and 268 can be manipulated with other than a thumb andfinger, respectively. It is anticipated, however, that a common usescenario may be for the latching mechanism to be manipulated with athumb and an index finger of a single hand. As illustrated in FIG. 6 andFIG. 7, the finger press surface 268 of the latching receiver 260 andthe thumb press surface 266 of the latching structure 250 are orientedin an oppositely-disposed manner. As shown, the opposing interaction ofthe latching structure 250 and the latching receiver 260 separated byspring 259 provides an arrangement in which the finger press surface 268and the thumb press surface 266 are operatively coupled with one anotherin close proximity. By manipulating thumb press surface 266 and fingerpress surface 268 and manually squeezing or urging surface 268 towardsurface 266, the latching mechanism can be urged relatively easily andergonomically into the latched state. As a measure against unintended oraccidental movement of the latching mechanism into the latched state,buttress 274 can act as a guard that help prevent an object on the frontside of assembly 200 from pressing against thumb press surface 266 orother part of FFP arm 246, thereby providing a guard against accidentallatching of the latching mechanism.

The latching mechanism also can be relatively easily and ergonomicallymanipulated to release the mechanism from the latched state or tounlatch FFP arm 246 such that it can be moved (by, for example, abiasing force of spring 258) to the free-flow preventing position. Toaid such a release manipulation, latching structure 250 of FFP arm 246can include a release catch 270 that a fingertip (for example) can exertforce against to release (or, colloquially, “unhook”) latching structure250 from latching surface 262. Release catch 270 can be structured toprovide purchase or a suitable surface thereon for a human finger toflex FFP arm 246 sufficiently to unlatch the latching mechanism. Releasecatch 270 can include one or more side extensions that extend to one orboth sides of FFP arm 246 (i.e., perpendicular to a plane of motion ofarm 246 relative to frame 200), somewhat resembling a cross-bar of theletter “T” in the illustrated embodiment.

In a non-limiting example of an ergonomic manipulation that can releasethe latching mechanism from the latched state (shown in FIG. 7), a usercan place a thumb on the thumb press surface 266 and/or the buttress274, and place a fingertip (for example, the tip of the index finger ofthe same hand as that of the thumb) on release catch 270. With referenceto both FIGS. 7 and 6, while bracing or holding the thumb against thumbpress surface 266 and/or buttress 274, the user can exert a forcegenerally toward the thumb (that is, to the right of FIG. 6). Under suchmanipulation, some flexure in FFP arm 246 can allow latching structure250 to move (upward, toward the top of FIG. 6) such that it no longerbears against latching surface 262. With this constraint removed orminimized FFP arm 246 can move, for example under the influence of thebiasing force of spring 258, to the free-flow preventing position ofFIG. 6 with peristaltic tube 202 thus being squeezingly occluded. Whenperforming the described manipulation with the index finger and thumb ofthe same hand, additional fingers of the same or another hand can beused to further brace or support assembly 200 during such manipulationsthereof. It has been observed that in some embodiments, the latchingmechanism of assembly 200 can be released readily by a usersingle-handedly, without the use of another hand. As described furtherelsewhere herein, the latching mechanism of assembly 200 also can bereleased readily upon coupling of the assembly 200 with an infusionpump.

FIG. 8 is a schematic perspective view of portions of a peristalticinfusion pump 800, which can be pump 102 of peristaltic infusion pumpsystem 100, particularly illustrating details of an assembly receptacle812 and a receptacle door 816 of the pump (in an embodiment,corresponding to assembly receptacle 112 and receptacle door 116 of FIG.1, respectively). Assembly receptacle 812 can be configured to receiveassembly 200 of administration set 104 such that the set 104 is therebyoperatively coupled to pump 800. FIG. 9 is a schematic perspective viewof portions of peristaltic infusion pump 800 of FIG. 8, with assembly200 received by or installed in assembly receptacle 812. In FIGS. 8 and9, receptacle door 816 of pump 800 is in an open position.

Frame 210 of assembly 200 can include a snap-fit tab 276 (see FIGS. 2,3, 4, 5) configured to securely and releasably attach to snap-fitopening 820 of assembly receptacle 812 (as shown in FIG. 8), such thatassembly 200 is thereby releasably secured to assembly receptacle 812,and accordingly, administration set 104 can thereby be operativelycoupled to pump 800. Snap-fit tab 276 can be formed integrally orotherwise provided with first beam 212 of frame 210, and project awayfrom the first plane of first beam 212 and second beam 214 in a firstdirection that can be substantially or approximately perpendicular tothe first plane. A snap release handle 278 (again, see FIGS. 2, 3, 4, 5)can be formed integrally or otherwise provided with first beam 212, withrelease handle 278 operatively coupled to tab 276. Release handle 278can project away from the first plane in a second direction generallyopposing the first direction, but other configurations are possible.First beam 212 can incorporate features to provide flexibility for tab276 and handle 278 relative to other portions of beam 212, such asnarrowing of the beam and/or structuring the beam as multiple sub-beams,as illustrated.

Snap release handle 278 and snap-fit tab 276 can be structured such thata defined manipulation of handle 278 can move tab 276 relative tosnap-fit opening 820 of assembly receptacle 812 such that tab 276 isreleasable from opening 820, and hence assembly 200 is therebyreleasable from assembly receptacle 812. The defined manipulation canbe, for example, to press or otherwise move snap release handle 278 in adownward direction relative to snap-fit opening 820 of assemblyreceptacle 812, which can result in snap-fit tab 276 moving upwardlyrelative to opening 820 of receptacle 812, as handle 278 and tab 276together flexibly rotate relative to first beam 212. Movement ofsnap-fit tab 276 upwardly relative to snap-fit opening 820 of assemblyreceptacle 812 can be such that tab 276 is thereby released from opening820. In addition, snap-fit tab 276 can be configured such that releasefrom snap-fit opening 820 does not necessarily require that the snaprelease handle 278 be manipulated. For example, in some instancesrelease of assembly 200 from assembly receptacle 812 can be achieved bypulling tubing (such as upstream tubing 126 and/or downstream tubing130) away from pump 800. The structural configuration of snap-fit tab276 may allow it to release from snap-fit opening 820 under the forcesexisting in such a scenario.

The aforedescribed arrangement for releasably securing assembly 200 toassembly receptacle 812 via snap-fit tab 276 and snap-fit opening 820,and thereby reversibly operatively coupling administration set 104 topump 800, can be a significant improvement in ergonomics anduser-friendliness as compared with other known schemes for couplingadministration sets to infusion pumps. In an example manipulation, auser can easily grasp assembly 200 with two fingers (e.g., thumb andindex finger) of a single hand via snap release handle 278, moveassembly 200 to assembly receptacle 812 of pump 800, and secure assembly200 to receptacle 812 by pressing snap-fit tab 276 of assembly 200 intosnap-fit opening 820 of pump 800. With this arrangement, the user mayneed only align snap-fit tab 276 with snap-fit opening 820 in order toachieve alignments of features of assembly 200 with correspondingfeatures of assembly receptacle 812 necessary or desirable for operationof infusion pump system 100 (such alignments are described furtherelsewhere herein). To remove assembly 200 from assembly receptacle 812,a user can ergonomically press down on snap release handle 278, whichcan move snap-fit tab 276 upwardly and thus out of engagement withsnap-fit opening 820, and then with two fingers, ergonomically pullassembly 200 away from receptacle 812.

Assembly 200 and assembly receptacle 812 can include features to preventadverse outcomes that potentially could result from attempts toimproperly insert, couple, or attach assembly 200 to receptacle 812 (andthus correspondingly, e.g., administration set 104 to pump 102). Forexample, if a user attempts to improperly insert snap release handle 278into snap-fit opening 820 (with assembly 200 reversed front-to-back,i.e., “backwards” relative to pump 800), physical dimensions of handle278 and opening 820 can be designed to interfere and prevent such animproper insertion attempt. Also, a potential error to be prevented isunintended depression of thumb press surface 266 or any other part ofFFP arm 246 that might result in unintended free-flow of an infusatethrough tube 202. Assembly 200 and assembly receptacle 812 can bestructured such that, when a backwards placement of assembly 200 intoreceptacle 812 is attempted, other elements of assembly 200 and/orreceptacle 812 can interfere before such an improper condition occurs.As noted elsewhere herein, buttress 274 can guard against unintendedcontact with FFP arm 246. Assembly 200 can include visual cues for theuser to encourage proper orientation of assembly 200 when coupling toassembly receptacle 812. This can include text and/or logo(s) (e.g.,“smiths medical” on second beam 214, directional arrows on first beam212, and the tear-drop shape on thumb press surface 266, as illustratedin, e.g., FIGS. 2-5). In some embodiments (not illustrated), an assemblyreceptacle such as receptacle 812 of pump 800 can include visual cuescorresponding to visual cues of assembly 200, such as the aforementioneddirectional arrows and “smiths medical” logo.

When assembly 200 is secured to assembly receptacle 812 via snap-fit tab276 of assembly 200 and snap-fit opening 820 of receptacle 812 in pump800, peristaltic tube 202 of assembly 200 can be positioned forengagement with tube-engaging members 818 of a linear peristaltic pumpdrive of pump 800. Tube-engaging members 818 (twelve members in theillustrated example of FIGS. 8 and 9, but this is not limiting) can bedriven in a coordinated manner by elements of a linear peristaltic pumpdrive (not illustrated) of pump 800 to thereby urge, push, or transportinfusate through, squeezingly, peristaltic tube 202 and thusresponsively through other tubes or lines connected fluidically theretosuch as (but not limited to) upstream tubing 126 and downstream tubing130 of infusion system 100 illustrated in FIG. 1.

As illustrated in, e.g., FIG. 2, frame 210 of assembly 200 can includefurther structures to assist in maintaining a desired position ofperistaltic tube 202, such as an upstream cross-support 280 and adownstream cross-support 282 that can span from first beam 212 to secondbeam 214. Each cross-support 280, 282 can include a curved section tocradle or otherwise supportingly hold peristatic tube 202. When assembly200 is secured to assembly receptacle 812 in pump 800, cross-supports280, 282 can also assist in maintaining a proper positon of peristatictube 202 relative to tube-engaging members 818 of pump 800 such thatmembers 818 are able to effectively engage tube 202.

First beam 212, second beam 214, upstream cross-support 280, anddownstream cross-support 282 can define, surround, or bound a pump tubeopening or “window” 284 of frame 210. Pump tube window 284 can besubstantially free of any structure of assembly 200 other than a portionof peristaltic tube 202 therewithin and generally can correspond to anarea where tube-engaging members 818 of pump 800 can engage tube 202when assembly 200 is secured to assembly receptacle 812 of pump 800. Asillustrated in FIG. 8, receptacle door 816 of pump 800 can include apressure plate 826 that can be, when door 816 is closed and secured (asdescribed in further detail elsewhere herein), positioned along tube 202generally opposite tube-engaging members 818 such that tube 202 islocated between pressure plate 826 and tube-engaging members 818. Whenin such a configuration, pump 800 and assembly 200 can be structuredsuch that, in an example embodiment, tube-engaging members 818 andpressure plate 826 substantially do not contact frame 210.

As illustrated in, e.g., FIG. 2, portions of frame 210 can define,surround, or bound further windows or openings that can correspond toother areas where components of pump 800 can engage with peristaltictube 202. For example, first beam 212, second beam 214, upstreamcross-support 280, and first end plate 216 can define, surround, orbound an upstream sensor opening or “window” 286 of frame 210; and firstbeam 212, second beam 214, downstream cross-support 282, and second endplate 218 can define, surround, or bound a downstream sensor opening or“window” 288 of frame 210. Pump 800 can include any or all of, inreceptacle 812, an upstream occlusion sensor 828, a downstream occlusionsensor 832, and an air-in-line detector 836, although this is notlimiting and other locations, combinations, or arrangements of sensorscan be included with pump 800. Upstream sensor window 286 can besubstantially free of any structure of assembly 200 other than a portionof peristaltic tube 202 and generally can correspond to an area whereupstream occlusion sensor 828 can engage tube 202 when assembly 200 issecured to assembly receptacle 812 of pump 800. Downstream sensor window288 can be substantially free of any structure of assembly 200 otherthan a portion of peristaltic tube 202 and generally can correspond toan area where downstream occlusion sensor 832 and/or air-in-linedetector 836 can engage tube 202 when assembly 200 is secured toassembly receptacle 812 of pump 800.

Receptacle door 816 of pump 800 can include tube supports 840, 844 thatcan be, when door 816 is closed and secured about assembly 200,positioned along tube 202 generally opposite, respectively, upstreamocclusion sensor 828, and downstream occlusion sensor 832 andair-in-line detector 836, such that tube 202 is located between tubesupports 840, 844 and occlusion sensors 828, 832, and air-in-linedetector 836. When in such a configuration, pump 800 and assembly 200can be structured such that, in an example embodiment, sensors 828, 832,detector 836, and tube supports 840, 844, substantially do not contactframe 210. In other embodiments, an assembly similar to assembly 200 caninclude tubing supports that can provide preload between a peristaltictube and pump sensors/detectors. Such tubing supports could be includedwith a frame similar to frame 210 of assembly 200.

As illustrated in, e.g., FIG. 8, assembly receptacle 812 of pump 800 caninclude features to accommodate and interact with FFP arm 246 ofassembly 200. In particular, surfaces of assembly receptacle 812 candefine, surround, or bound a recess 848 dimensioned to permit generallyunhindered motion of the FFP arm 246 between free-flow preventing and afree-flow allowing positions when assembly 200 is installed in pump 800.Toward a top portion of recess 848, surfaces of assembly receptacle 812can include at least one latch ramp 852. Latch ramp(s) 852 in receptacle812 of pump 800 and release catch 270 of assembly 200 can be structuredto cooperate so that when assembly 200 is placed in and/or secured toassembly receptacle 812, a portion or portions of release catch 270(such as side extensions thereof) substantially slide along latchramp(s) 852 as FFP arm 246 of assembly 200 is moved toward the free-flowallowing position. Contact forces thus exerted on release catch 270 ofFFP arm 246 by latch ramp(s) 852 during such sliding interactions canflex the arm 246 sufficiently to prevent the latching mechanism fromlatching in the free-flow allowing position. As discussed elsewhereherein, FFP arm 246 can be moved toward the free-flow allowing positionwhen receptacle door 816 is closed and a door latch lever 856 is movedfrom its unlatched position (as illustrated in, e.g., FIG. 10) to itslatched position (as illustrated in, e.g., FIG. 11). Latch ramp(s) 852can substantially inhibit or prevent the latching mechanism fromlatching in the free-flow allowing position during such an action.Furthermore, if the latching mechanism is latched in the free-flowallowing position before assembly 200 is secured to assembly receptacle812, then when assembly 200 is secured to receptacle 812 (by pressingsnap-fit tab 276 into snap-fit opening 820 as aforedescribed), latchramp(s) 852 can exert force on release catch 270 sufficient to flex FFParm 246 enough that the latching mechanism is released, thereby allowingFFP arm 246 to be biased (for example, by spring 258) to the free-flowpreventing position. This can be an important safety feature, helping toensure that administration set 104 is in a non-free-flow state initiallywhen it is secured to the pump.

As illustrated in, e.g., FIG. 8, assembly receptacle 812 of pump 800 caninclude an optical device 860 that can be configured and used to detecta presence of and/or identify a particular or different type or unit ofassembly 200 received by assembly receptacle 812 of pump 800. An opticalreference/calibration portion 864 can be included in or on door 816,generally within view of optical device 860 when door 816 is closed andassembly 200 is not received by assembly receptacle 812. Optical device860 can include any suitable hardware for opticaldetection/identification, including but not limited to light sources,imaging and/or non-imaging light sensors, polarization-activecomponents, and light redirecting components, such as refractive,reflective, and/or diffractive elements. In some embodiments, opticaldevice 860 can be configured to detect color, and particular ordifferent types or units of assembly 200 can be differently or uniquelycolored to encode different infusion applications, therapies, orprocedures for which their corresponding administration sets 104 areconfigured and intended. For example, in some healthcare environments, ayellow color scheme is commonly identified by medical practitioners aspertaining to epidural procedures, and an orange color scheme iscommonly identified by medical practitioners as pertaining to enteralprocedures. (It should be noted that such color associations are notnecessarily universal and may vary between hospitals, institutions,regions, practices, etc.) In some embodiments, a substantial portion oressentially all of frame 210 of assembly 200 can bear or exhibit a coloridentifying a particular infusion application, therapy, or procedure.The use of such identifying colors may permit caregivers to quicklyrecognize an intended application, therapy, or procedure for anadministration set 104, and optical device 860 can provide thecontroller of pump 800 with administration set identifying information.With such information, the controller could then configure or programitself and/or pump 800 for the infusion application, therapy, orprocedure.

After assembly 200 is received by assembly receptacle 812, door 816 canbe rotated closed about hinges 868 (as shown in, e.g., FIG. 8) and doorlatch lever 856 can be moved from an unlatched position to a latchedposition as shown in FIGS. 9-11. FIG. 10 is a schematic perspective viewof portions of pump 800 with door 816 in the closed position and doorlatch lever 856 in the unlatched position. FIG. 11 is a schematicperspective view of portions of pump 800 with door 816 in the closedposition and door latch lever 856 in the latched position. It is to beunderstood that in FIGS. 8 and 9, door 816 is in a fully orsubstantially open position, but the door latch lever 856 is arbitrarilyin what would otherwise be the latched position in FIG. 8 and theunlatched position in FIG. 9, to illustrate features on an interior ofdoor 816 that depend on position or movement of door latch lever 856.For example, as shown in FIGS. 8 and 9, door 816 can include one or moredoor latch hooks 872 corresponding to one or more door latch pins 876 ofreceptacle 812. Door latch hooks 872 can be mechanically linked to doorlatch lever 856 to responsively move as lever 856 is moved betweenlatched and unlatched positions. When door 816 is closed and door latchlever 856 is in the latched position, door latch hooks 872 can beresponsively positioned relative to door latch pins 876 to engaginglyconstrain or latch door 816 in the closed position. When door latchlever 856 is in the unlatched position, door latch hooks 872 can beresponsively positioned to dis-engagingly not interfere with door latchpins 876 as door 816 is moved into and out of the closed position.

As also shown in FIGS. 8 and 9, door 816 can include an FFP arm pusher880 that can be mechanically linked to door latch lever 856 to move aslever 856 is moved between latched and unlatched positions. In someembodiments, FFP arm pusher 880 can be provided integrally on astructure of door latch hook 872. FFP arm pusher 880 can be operativelycoupled to door latch lever 856 and configured such that when assembly200 is received by assembly receptacle 812 and door 816 is closed, FFParm pusher 880 pushes FFP arm 246 (for example, by exerting force on arm246 at thumb press surface 266 and/or other parts of arm 246) from thefree-flow preventing position to the free-flow allowing position as doorlatch lever 856 is moved to the latched position. When door latch lever856 is returned to the unlatched position, FFP arm pusher 880 canresponsively retract, thereby allowing the biasing force provided by,for example, spring 258 to return FFP arm 246 to the free-flowpreventing position. As described elsewhere herein, latch ramp(s) 852can prevent the aforementioned latching mechanism for FFP arm 246 fromlatching when assembly 200 is received by assembly receptacle 812. Thearrangement described herein can be an important safety feature, to aidin substantially ensuring that FFP arm 246 is in the free-flowpreventing state when the door 816 is opened and assembly 200 is removedfrom pump 800.

To review an example of operation of cooperative and/or responsivelyactuated free-flow protection mechanisms of assembly 200 and pump 800, apotential sequence of actions is presented here with reference to FIGS.1-11. An administration set 104 that includes assembly 200 can becoupled to an infusate reservoir such as an IV bag 120. Optionally, toprime administration set 104, a caregiver can latch FFP arm 246 ofassembly 200 into the free-flow allowing state with the latchingmechanism. After priming, the caregiver can unlatch the latchingmechanism by, for example, manipulating release catch 270 asaforedescribed. The caregiver can secure assembly 200 to assemblyreceptacle 812 by grasping snap release handle 278, moving assembly 200to receptacle 812, and pressing snap-fit tab 276 into snap-fit opening820. If the latching mechanism remains latched immediately beforeassembly 200 is placed into or secured to receptacle 812, then as tab276 is pressed into opening 820, latch ramp(s) 852 can exert force onrelease catch 270 sufficient to release the latching mechanism, and FFParm 246 can thereby be biased (for example, by spring 258) to thefree-flow preventing position.

With assembly 200 secured to assembly receptacle 812, the caregiver canthen close door 816. As door 816 is rotated or moved into its closedposition, pressure plate 826 can come into position along a portion ofperistaltic tube 202 opposite tube-engaging members 818, and tubesupports 840, 844 can come into position along a portion of tube 202opposite occlusion sensors 828, 832 and detector 836. To bring door 816to its fully-closed position, if door latch lever 856 is in the latchedposition, it may be necessary to move it to the unlatched position,otherwise door latch hooks 872 may interfere with latch pins 876. Withdoor 816 in its fully-closed position, door latch lever 856 can be movedto the latched position. As door latch lever 856 is moved to the latchedposition, door latch hooks 872 can responsively move as aforementionedto their latched positions where they can extend or hook around doorlatch pins 876 to aid in preventing door 816 from unintentionallyopening. As door latch hooks 872 are moved to their latched positions,FFP arm pusher 880 can progressively push FFP arm 246 to the free-flowallowing position. However, with door 816 fully closed, sometube-engaging members 818 and pressure plate 826 can occlude tube 202simply by virtue of their presence and thus prevent free-flow, even withFFP arm 246 in the free-flow allowing position.

At any suitable time, which may be before or after door 816 is closed,upstream and downstream tubing 126, 130 (not illustrated in FIG. 9-11)can be manually pressed into tube guides 884.

After completion of infusate delivery by pump 800 or at any suitabletime, door latch lever 856 can be moved from the latched to theunlatched position before opening door 816. As door latch lever 856 ismoved to the unlatched position, FFP arm pusher 880 can retract,allowing FFP arm 246 to be biased to the free-flow preventing position.After door 816 is opened subsequently, assembly 200 can be released fromassembly receptacle 812 via manipulation of snap release handle 278, andadministration set 104 can be decoupled, disengaged, or removed frompump 800 with FFP arm 246 in the free-flow preventing position. Prior tomoving door latch lever 856 to the unlatched position, free-flow wouldbe prevented by tube-engaging members 818 and pressure plate 826 asaforementioned. Thus, prevention of free-flow can be maintainedsubstantially continuously from when assembly 200 is secured to assemblyreceptacle 812, to a later time after the assembly is removed from thereceptacle.

Of note, any or all of the actions in the aforedescribed potentialsequence of actions can be performed using only a single hand (forexample, but not necessarily limited to: latching and unlatching FFP arm246, securing and releasing assembly 200 to/from receptacle 812, closingand opening door 816, and moving door latch lever 856 between latchedand unlatched positions). This can contribute significantly to ease ofuse of the infusion pump sy stem.

It is to be appreciated and understood that, although not illustrated inthe Figures, in another embodiment an assembly similar in some aspectsto assembly 200 can be provided that includes free-flow protection, butno latching mechanism, and/or a different latching mechanism structureor configuration. A free-flow protection arm can be provided that doesnot include a latching structure like latching structure 250 of FFP arm246. Without a latching structure, such an alternative free-flowprotection arm would not necessarily need to provide flexure (which FFParm 246 can provide to enable release of latching structure 250 fromlatching receiver 260 as shown in, e.g., FIGS. 6 and 7). Such afree-flow protection arm could be configured to be, for example,compatible with assembly receptacle 812 of pump 800, and particularly,be operable with FFP arm pusher 880 to move the free-flow protection armbetween free-flow allowing and preventing positions as door latch lever856 is moved between latched and unlatched positions, respectively.

It is also to be appreciated and understood that, although notillustrated in the Figures, in another embodiment that does not have alatching mechanism that is integrally provided with a free-flowprotection arm and frame, a separate latching clip or device could beprovided to secure the free-flow protection arm in a free-flow allowingposition for purposes such as priming or gravity administration. Such aseparate latching clip or device could be shaped or structured such thatthe latching clip or device prevents (for example, via mechanicalinterference) operatively coupling the assembly to the pump when theclip or device is securing the free-flow protection arm in a free-flowallowing position. Thus, the separate clip or device would be detachedor deactivated prior to operatively coupling the assembly to the pump,thereby satisfying free-flow safety objectives or requirements.

Alternatively, or in addition to the arrangement shown in FIG. 8 havingan optical sensor 860, other sensing devices or means 860A (as will bedescribed with reference to, e.g., FIG. 13) for identification of anassembly 200 are contemplated as well. Such sensing devices 860A can beused to readily identify an intended “route” of infusion, application,therapy, procedure, or other grouping of assemblies 200.

Some examples of alternate sensing devices 860A are disclosed anddescribed in FIGS. 13-17C and the following discussion. In FIG. 13, apump 800A is shown having an assembly receptacle 812A and a sensingdevice 860A. To the extent features of FIG. 13 are not specificallydescribed in the following disclosure, they should be understood asbeing consistent with the discussion and corresponding referencenumerals associated with FIG. 8. A corresponding assembly 200A formating with the pump 800A of FIG. 13 is shown in FIG. 14. To the extentfeatures of FIG. 14 are not specifically described in the followingdisclosure, they should be understood as being consistent with thediscussion and corresponding reference numerals associated with FIG. 3.

In general, sensing device 860A of FIG. 13 can be one or more sensors ofvarious types and detection capabilities. In some embodiments,identification sensor 860A can include components for detection based onone or more of: magnetic keying, pin configurations, size, shape, radiofrequency identification (RFID), near field communication (NFC), orother identification technology. In certain embodiments, sensing device860A could include variations of an optical sensor 860, as describedearlier in FIG. 8, as well.

Grouping of assemblies 200A based on an assembly's intended “route”(i.e. location where the medication is going) of medication delivery canhave a variety of benefits especially when these groups can be rapidlyand reliably identified by using sensing devices 860A (or 860). In someembodiments, one or more of the sensing devices 860A allow a pump todetect the intended “route” of infusion based on identifiers present onan attached assembly 200A. For example, the “route” of infusion couldinclude delivery: intravenously, via mouth, via feeding tube; or viaalternate injection location. Identification of the “route” can be auseful grouping as the route can define the hardware needed.Accordingly, knowing the “route” is typically determinative of theassembly 200A (or larger disposable set) needed to accomplish aparticular infusion. Sensing the route of infusion, not just thephysical properties of the assembly being used, provides an assemblytype or disposable set tied to the performance of the pump, and allowsfor automatically filtering the drug library to correspond to thatassembly type or disposable set. PCT patent publication WO2016/018552A1to Blomquist, published Feb. 4, 2016, entitled “Medicament

Infusion System and Pump Assembly for Use Therein, further relates toidentifying an infusion route to a pump and other systems, methods andmaterial, and is hereby fully incorporated by reference herein.

Detection of identification information of the assembly 200A can beuseful both for authentication purposes as well as for ease ofprogramming purposes. With respect to authentication of the assembly200A, verification that the assembly 200A is being delivered via thecorrect route, or in accordance with another parameter, will help toreduce user errors and provide a method of identifying authenticassemblies 200A. Identifying authentic assemblies 200A which are madeaccording to approved specifications and/or by authorized suppliers canprovide desirable safety benefits to users as well.

With respect to programming, detecting the route of infusion enables thepump 800A to automatically begin the programming process for a desiredroute or type of administration upon attachment of the disposableassembly 200A to the compatible infusion pump. Immediate recognition ofthis information by the pump can simplify the programming steps requiredfor infusion to occur, shorten the time-period to begin infusion, andeliminate certain sources of potential programming errors.

FIG. 14 sets forth an example of an assembly 200A, similar to thearrangement of FIG. 3, in which a back schematic perspective view of theassembly 200A can be seen. In FIG. 14, one or more areas on the assembly200A serve as an identifier 861A, based on color or other identifyingfeature. In some cases, the identifier 861A is a colored surface or tag.In some embodiments, this color can provide an associated visible orinfrared optical wavelength for detection. As depicted on FIG. 14, theflat area on securement plate 224 a could be used for an identifier861A, for example.

Therefore, a general peristaltic pump identification arrangement can beunderstood from a combination of the components of FIGS. 13 and 14.Specifically, a general identification arrangement may include a sensingdevice 860A on a pump 800A (as shown in FIG. 13) and an identifier 861Aon the assembly 200A (as shown in FIG. 14). Although dependent on theidentification technology used, in general, the sensing device 860Aserves as a “reader” and the identifier 861A, located on a matingassembly 200A, serves as the source of identification data. Assembly200A can be constructed with an identifier permanently installed orcoupled to the assembly 200A in some embodiments. The mating infusionpump 800A would have an appropriate reader or sensing device 860A toautomatically identify the assembly 200A being attached to the infusionpump 800A to begin the programming process. Using this type ofidentification arrangement provides a robust method of identifyingassemblies 200 and reduces user error.

In some embodiments, the identifier 861A may relate to the color of thetubing passing through the assembly 200A, rather than a separateidentifier 861A on the assembly 200A. Further, the identifier 861A maybe understood to be located on any type or configuration of assembly200A and is not limited in any way by the assemblies and embodimentsdisclosed herein in the figures or specification. Certain assemblies mayinclude one or more identifier(s) 861A on a frame 210 defining theassembly. Other embodiments include one or more identifier(s) 861A justoutside an assembly frame structure 210. Other embodiments may relate toidentifiers 861A on a non-unitary frame and/or multi-part framestructure. Some assemblies may have no specifically-defined framestructure at all.

In some embodiments, identifiers 861A could be sensed on or in as partof component parts of an assembly 200A such as Y-sites, stopcocks, theFFP arm 246, the FFP spring 258, slide clamps or tube couplers.Likewise, the sensing device 860A used may be viewed as non-limiting invarious respects. The sensing device 860A may be aligned outboard of theframe 210 or inboard of the frame 210.

Detection of assemblies 200A based on magnetic keying can be utilizedfor identification in some embodiments. In these embodiments, thesensing device 860A can include a Hall Effect sensor or other deviceused to vary an inductive field. The sensing device 860A can function asa reader of a magnetic key or identifier 861A on the assembly 200A.Accordingly, the identifier 861A provides identification data via themagnetic key.

In some magnetic key arrangements, sensing devices 860A sense a rotatingmagnetic field via an encoder. In some embodiments, a microprocessorchip can be mounted to the pump 102. The device can be arranged suchthat different disposables will provide a different magneticorientation. In some linear magnetic embodiments of sensing devices860A, sensors will place North/South magnets (i.e. shown as “N” forNorth and “S” for South in the figures) in a row. In some embodiments,industrial motor sensors will provide absolute or relative positions.Such sensing arrangements can provide the ability to utilize a singlesensor to sense multiple keys.

FIGS. 15A-E provide examples of sensing devices 860A capable ofproviding magnetic keying capabilities. FIG. 15A shows a sensing device860A comprised of a magnetic rotary encoder 902 on a processing chip904. Sensors of this type may be contactless and integrate field sensingHall elements, analog front-end, and digital signal processing in someembodiments. The rotary position is contactlessly sensed by a smallrotating magnet that is placed above the device to identify a particularassembly or designated “route”. Small absolute positions of a full turnmay be sensed in some embodiments permitting resolutions of factions ofa degree in some cases.

FIGS. 15B and 15C depict sensing devices 860A which can rely on magnetickeying by detecting linear motion and off-axis rotational measurements.FIG. 15B shows an example of a sensing device 860A combining Halleffects and a signal processor. Specifically, magnetic strips 912 havinga pole-pair are coupled with signal processor 914. Accordingly, assemblyidentification/information can be obtained based on linear magneticmovement. In FIG. 15C, another embodiment is shown containing apole-paired magnetic rings 922 and signal processor 924. Pole-pairedmagnetic rings 922 like this can provide a very high resolution ofpositions per revolution and can operate at significant RPMs.

FIGS. 15D and 15E shown examples of sending devices 860A that utilizemagnetic keying with sensors including a Hall effect latch which detectsboth “vertical” and “horizontal” magnetic fields at the same time. Theseeach contain a magnetic rotary encoder 932 and processor 934. As shownin FIG. 15D, the results can be read out to A and B pins as depicted at936. In FIG. 15E, pulse and rotational direction can be output asdepicted at 938. Numerous variations and/or combinations of suchmagnetic keying devices may be utilized as sensing devices 860A.

In other embodiments, detection of assemblies 200A can be based on keyedpin configurations. These pin configurations can be mechanical orelectrical and can include push pins or interfaces for receivingpatterned pin arrangements on the sensing device 860A. The particularidentifying geometry present on the corresponding assembly 200A willcommunicate the intended route or other identifying information to thesensing device 860A. Examples of possible sensing device configurationswith receptacles or contacts 940 for receiving or providing engagingpins are shown in the top view depictions of FIGS. 16A-C and theperspective view embodiment of FIG. 16D. Corresponding engaging pins orcontacts would be present on the identifier 861A of the assembly 200A.

In some embodiments, the pin configuration or patterned arrangement willbe presented as an electric matrix array. Accordingly, such sensingdevices 860A permit simultaneous force measurements across a grid ofcells. Matrix arrays can be used for capturing static and dynamicfootprints or multi-touch user inputs in some embodiments. In some casesa matrix arrangement can even include memory to store more detailedinformation that could be received by a pump 102.

Detection using pins or other features can rely upon physicalgeometries, as referenced in FIGS. 16A-D. Alternatively, electricalgeometries may be utilized. Rather than detection by shapes ormechanical pins relying on an on/off switch, a force sensor array isused to detect an amount of force. Electric geometries can rely uponsensing variable resistance with a sensing device to interpret theelectric geometries presented. Accordingly, the “keys” are the means forproviding variable resistance associated with a particular assembly. Insome cases, capacitance or inductance could be used as “keys” as well.In some cases electrical geometries can even include memory to storemore detailed information that could be received by a pump 102.

FIG. 16D shows one example of a pogo-pin design which can be based onmechanical and/or electrical geometries. Pins 950 provide “keys” toidentifying an attached assembly 200A (or information, such asmedication “route”) to an assembly receptacle 812A or a pump 102. Somepogo-pins may include internal springs or other resilient mechanisms formaking contacts, for example.

Other forms of identification and detection based on identifyingprotrusions of particular sizes and shapes are possible as well. Incertain embodiments, features are present on the sensing device 860A formatching and detecting geometric features of an assembly 200A. Featurespresent on the sensing device 860A can include flanges or nestedrecesses 960, for example. Examples of interfaces or design features ofpossible sensing devices 860A for receiving specially sized and shapedprotrusions present on identifier 861A of assemblies 200A are shown inFIGS. 17A-C.

As discussed above, detection using specifically shaped features canrely upon physical geometries or electrical geometries. A force sensorarray may be used to detect an amount of force in some instances.Electric geometries can rely upon sensing variable resistance, etc.Sensing resistance, capacitance or inductance can be used as “keys”.

Detection of characteristics of an assembly 200A can also be based onRFID technology. In some embodiments, an RFID reader can be used as thesensing device 860A within the pump 800A. Further, the assembly 200A canprovide an RFID tag, as an identifier 861A, which could store andprovide various pieces of information to the RFID reader regarding theassembly 200A. This information may include one or more of: “route” ofinfusion, application, therapy, procedure; date of manufacture; lotnumber of manufacture; manufacturing site; date of expiration; use;primary volume; upstream volume; downstream volume; alarms; programminginformation; for example. Tracking manufacture information has many usesand can enable additional safety and functionality options. For example,tracking manufacture information can help ensure that any issues thatare encountered with assemblies 200A can be readily isolated and dealtwith promptly. Tracking information can be used to trigger a variety ofalarms. Tracking dates can alert users to when infusate is no longersafe to use and replacement is required. Tracking infusate volumeenables better and more precise planning of infusion delivery and timingof replacements. While transferring these types of information isdiscussed in relation to RFID technology, similar information could alsobe conveyed using one or more of the other technologies for sensingdevices 860 or 860A discussed in this document.

Detection based on Near Field Communications (NFC) is another way to useappropriate sensing devices 860A on the pump and identifier 861A on theassembly 200A to provide a low power option for identification.

In certain embodiments, the information acquired via the sensing device860A will be utilized for auto programming (or “smart pump programming”)of the pump 800. Auto programming can help eliminate infusion errors andprovide more prompt and timely patient care. In some auto programmingembodiments, a manual override of programming is provided as well forpatient safety.

In some cases, the identification sensor 860A may be color sensor 860that relies on sensing visible light and/or infrared (IR) light. A colorsensor 860 can use an IR channel for detection of IR properties of theassembly 200. By relying on an IR channel for identification, the sensor860 can detect variations in color of an assembly 200 that are notreadily visible to users. Accordingly, use of the IR channel may helpdeter or prevent unauthorized assemblies 200 from being used asnon-visible device authorization information can be more challenging toreplicate by unauthorized manufacturers or suppliers of such assemblies200.

Similarly, in some cases, a pump 800 could be programmed to recognizeand respond to a very specific “Pantone” color or specific color range.In such an embodiment, the specific color could indicate a route ofinfusion, or provide a virtual key to prevent use of unauthorizedassemblies 200, or provide a combination of both an indication of routeof infusion and a virtual key to prevent use of unauthorized assemblies200. For example, an unauthorized assembly 200 without the right Pantonecolor or specific color range as an identifier 861A would not work inthe pump 800. In general, the various identification sensors 860A,including various forms of color sensor 860, can prevent an assembly 200from working with a pump 200 if the proper authentication information isnot detected. Authentication features which restrict the use ofassemblies 200 can vary significantly and are not limited by the typesof authentication specifically disclosed herein.

In some embodiments, the identifier 861A on the assembly 200 or 200A isa colored label or other adhereable or insertable, permanent ortemporary, identifying tag. In other embodiments the color, oridentifier 861A is part of or integral to the frame or structure of theassembly 200 or 200A. The location of the identifier 861A may vary onthe frame of assembly 200 or 200A. Likewise, the location of the sensingdevice 860A may vary within the assembly receptacle 812A of the infusionpump 800A.

As shown in FIG. 13, a reference/calibration portion 864A can beincluded in or on door 816A of the pump 800A in some embodiments. Thereference/calibration portion 864A can be configured to be in closeproximity or generally adjacent the sensing device 860A when door 816Ais closed and assembly 200A is not received by assembly receptacle 812A.In some cases, the reference/calibration portion 864A may be a self-testlabel which causes the pump to signal a need for or otherwise prompt aself-test, whether automatic or manually-initiated, when no assembly200A is inserted to obstruct or otherwise prevent the sensing devicefrom reading the self-test label of the portion 864A.

Specifically, a self-test label, such as reference/calibration portion864A, may identify a “no disposable condition” or “no assemblycondition” when no assembly 200A is inserted in assembly receptacle812A. This may be a label displaying a particular color that is capableof being optically sensed, for example. Other types of “no disposablecondition” or “no assembly condition” labels or components are possibleas well. Therefore, the pump 800A can readily and immediately detectwhen no disposable is installed and operate accordingly. By thisfeature, the pump 800A has a greater awareness of its currentconfiguration and capabilities.

In certain embodiments, such as those relying upon a color on theassembly 200 or 200A to convey infusion “route” or other identificationinformation, the color may further be recognized by the pump andautomatically implemented as the background color in the pump graphicuser interface (GUI). The consistent use of color for a particular“route” or other identification grouping can provide an intuitive anduser-friendly control for a user. This type of consistency can helpminimize or avoid user mistakes and human error.

Persons of ordinary skill in arts relevant to this disclosure andsubject matter hereof will recognize that embodiments may comprise fewerfeatures than illustrated in any individual embodiment described byexample or otherwise contemplated herein. Embodiments described byexample or otherwise contemplated herein are not meant to be anexhaustive presentation of ways in which various features may becombined and/or arranged. Accordingly, the embodiments are not mutuallyexclusive combinations of features; rather, embodiments can comprise acombination of different individual features selected from differentindividual embodiments, as understood by persons of ordinary skill inthe relevant arts. Moreover, elements described with respect to oneembodiment can be implemented in other embodiments even when notdescribed in such embodiments unless otherwise noted. Although adependent claim may refer in the claims to a specific combination withone or more other claims, other embodiments can also include acombination of the dependent claim with the subject matter of each otherdependent claim or a combination of one or more features with otherdependent or independent claims. Such combinations are proposed hereinunless it is stated that a specific combination is not intended.Furthermore, it is intended also to include features of a claim in anyother independent claim even if this claim is not directly madedependent to the independent claim.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of Section 112 (f) of 35 U.S.C. are not to be invokedunless the specific terms “means for” or “step for” are recited in aclaim.

1-32. (canceled)
 33. An assembly configured to position a peristaltictube with respect to a linear peristaltic pump drive of an infusionpump, the assembly comprising: a frame fixedly coupled to both the firsttube coupler and the second tube coupler, the frame configured to bereleasably coupled to the infusion pump such that the peristaltic tubeis placed in contact with the linear peristaltic pump drive; a firsttube coupler and a second tube coupler, each configured to be connectedto opposing ends of the peristaltic tube and each having a lumen influidic communication with the peristaltic tube; a free-flow preventionarm hingedly coupled to the frame and having a latching structureconfigured to cooperate with a latching receiver of the frame, thelatching structure including a thumb press surface oppositely-disposedof the latching receiver and a release catch offset a distance from thethumb press surface, the free-flow prevention arm configured toalternate between a closed position and an open position by pivoting ina direction that is substantially perpendicular to a longitudinal axisof the peristaltic tube such that the release catch is configured togrip a latching surface of the latching receiver, wherein in the closedposition the free-flow prevention arm and the frame compressivelyocclude the peristaltic tube, and in the open position the free-flowprevention arm and the frame allow the peristaltic tube to passtherebetween such that the peristaltic tube is not occluded; and abiasing mechanism located between the frame and the free-flow preventionarm, the biasing mechanism configured to bias the free-flow preventionarm to the closed position.
 34. The assembly of claim 33, wherein thelatching receiver of the frame includes a finger press surface.
 35. Theassembly of claim 33, wherein the release catch of the latchingstructure of the free-flow prevention arm is structured to provide asurface for a human finger to flex the free-flow prevention armsufficiently to unlatch a latching mechanism provided by the latchingstructure and the latching receiver.
 36. The assembly of claim 33,wherein the release catch of the latching structure of the free-flowprevention arm is structured to cooperate with at least one ramp in anassembly receptacle of the infusion pump so that when the assembly issecured to the assembly receptacle, the release catch slides along theat least one ramp as the free-flow prevention arm is moved toward theopen position, such that force exerted on the release catch by the atleast one ramp flexes the free-flow prevention arm sufficiently toprevent a latching mechanism provided by the latching structure and thelatching receiver from latching in the open position.
 37. The assemblyof claim 33, wherein the release catch of the latching structure of thefree-flow prevention arm is structured to cooperate with at least oneramp in an assembly receptacle of the infusion pump such that if, beforethe assembly is secured to the assembly receptacle, a latching mechanismprovided by the latching structure and the latching receiver is latchedin the open position, then subsequently when the assembly is secured tothe assembly receptacle via a snap-fit tab, the at least one ramp exertsforce on the release catch adequate to flex the free-flow prevention armsufficiently that the latching mechanism is released.
 38. The assemblyof claim 33, wherein the biasing mechanism includes a spring formedseparately from the frame and from the free-flow protection arm, thespring being captured between the frame and the free-flow protectionarm.
 39. The assembly of claim 33, wherein the free-flow prevention armis hingedly coupled to the frame at an arm end.
 40. The assembly ofclaim 39, wherein the free-flow prevention arm is hingedly coupled tothe frame at the arm end via a hinge mechanism that substantially doesnot impart torque between the free-flow prevention arm and the frame.41. The assembly of claim 33, wherein a latching mechanism provided bythe latching structure and the latching receiver is ergonomicallymanipulable with a single hand to latch the free-flow prevention arm inthe open position.
 42. The assembly of claim 33, wherein a latchingmechanism provided by the latching structure and the latching receiveris ergonomically manipulable with a single hand to unlatch the free-flowprevention arm such that the biasing mechanism is able to bias thefree-flow prevention arm to the closed position.
 43. The assembly ofclaim 33, wherein the frame defines a slot transverse to the peristaltictube and generally aligned with the free-flow prevention arm, such thatwhen the free-flow prevention arm is in the closed position, thefree-flow prevention arm presses the peristaltic tube at least partiallyinto the slot.
 44. The assembly of claim 43, wherein the frame includesa buttress spanning the slot, the buttress generally aligned with theperistaltic tube.
 45. The assembly of claim 44, where the buttressprovides a guard against accidental latching of a latching mechanismprovided by the latching structure and the latching receiver.
 46. Theassembly of claim 33, wherein the frame includes a first beam and asecond beam.
 47. The assembly of claim 46, wherein at least one of thefirst and second beams is substantially L-shaped.
 48. The assembly ofclaim 33, further comprising a first securement plate.
 49. The assemblyof claim 48, wherein the first securement plate includes an identifiercontaining information related to a route of infusion associated withthe assembly.
 50. The assembly of claim 49, wherein the identifier is acolored surface or tag providing an associated visible or infraredoptical wavelength for detection.
 51. The assembly of claim 49, whereinthe identifier contains at least one of: an RFID tag, a magnetic key, anidentifying pin configuration, and an identifying protrusion.
 52. Anassembly configured to position a peristaltic tube with respect to alinear peristaltic pump drive of an infusion pump, the assemblycomprising: a frame fixedly coupled to both the first tube coupler andthe second tube coupler, the frame configured to be releasably coupledto the infusion pump such that the peristaltic tube is placed in contactwith the linear peristaltic pump drive; a first tube coupler and asecond tube coupler, each configured to be connected to opposing ends ofthe peristaltic tube and each having a lumen in fluidic communicationwith the peristaltic tube; a free-flow prevention arm hingedly coupledto the frame and having a latching structure configured to cooperatewith a latching receiver of the frame, the latching structure includinga thumb press surface oppositely-disposed of the latching receiver and arelease catch offset a distance from the thumb press surface, thefree-flow prevention arm configured to alternate between a closedposition and an open position by pivoting in a direction that issubstantially perpendicular to a longitudinal axis of the frame suchthat the release catch is configured to grip a latching surface of thelatching receiver, wherein in the closed position the free-flowprevention arm and the frame compressively occlude the peristaltic tube,and in the open position the free-flow prevention arm and the frameallow the peristaltic tube to pass therebetween such that theperistaltic tube is not occluded; and a biasing mechanism locatedbetween the frame and the free-flow prevention arm, the biasingmechanism configured to bias the free-flow prevention arm to the closedposition.